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The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy

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ClinicalTrials.gov Identifier: NCT03647930
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Health University Medical Center

Brief Summary:
Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.

Condition or disease Intervention/treatment Phase
Seroma Device: Microporous Polysaccharide Hemospheres (MPH) Not Applicable

Detailed Description:

Seroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities. Microporous Polysaccharide Hemospheres (MPH) consists of hydrophilic, plant based, polysaccharide particles and is currently used as an absorbable hemostatic agent. An animal model evaluating MPH and seroma formation after mastectomy with axillary lymph node dissection showed a significant decrease in seroma volume. Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.

Prospective randomized single-blinded clinical trial of patients undergoing mastectomy for the treatment of breast cancer. MPH was applied to the surgical site in the study group and no application in the control group.

Fifty patients were enrolled; eight were excluded due to missing data. Forty-two patients were evaluated, control (n=21) vs. MPH (n=21). No difference was identified between the two groups regarding demographics, tumor stage, total drain days, total drain output, number of clinic visits, or complication rates. On a subset analysis, body mass index (BMI) greater than 30 was identified as an independent risk factor for high drain output. Post hoc analyses of MPH controlling for BMI also revealed no statistical difference.

Unlike the data presented in an animal model, no difference was demonstrated in the duration and quantity of serosanguinous drainage related to the use of MPH in patients undergoing mastectomy for the treatment of breast cancer. BMI greater than 30 was identified as an independent risk factor for high drain output and this risk was not affected by MPH use.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy: A Prospective Randomized Trial
Actual Study Start Date : May 15, 2012
Actual Primary Completion Date : March 6, 2015
Actual Study Completion Date : March 6, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Mastectomy

Arm Intervention/treatment
Experimental: Intervention
Application of Microporous Polysaccharide Hemospheres (MPH)
Device: Microporous Polysaccharide Hemospheres (MPH)
Microporous Polysaccharide Hemospheres (MPH)

No Intervention: Control
No MPH



Primary Outcome Measures :
  1. Total Drain Days [ Time Frame: 23 Days ]
    Time to Drain Removal

  2. Total Drain Output [ Time Frame: 23 Days ]
    Total Drain Output in mL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Undergoing simple mastectomy with or without sentinel lymph nodes biopsy OR modified radical mastectomy for the treatment of breast cancer

Exclusion Criteria:

  • Undergoing partial mastectomy
  • Sentinel lymph node biopsy requiring conversion to axillary lymph node dissection
  • Immediate reconstructive surgery
  • Systemic anticoagulation
  • Choosing not to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647930


Locations
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United States, Georgia
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Sponsors and Collaborators
Memorial Health University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Memorial Health University Medical Center
ClinicalTrials.gov Identifier: NCT03647930     History of Changes
Other Study ID Numbers: MHUMC 2012.05.05
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Postoperative Hemorrhage
Pathologic Processes
Hemorrhage
Postoperative Complications